Idera Pharmaceuticals, Inc. (Nasdaq: IDRA), or Idera or the
Company, today is providing an update on its tilsotolimod clinical
development program and providing a corporate outlook for 2020.
“We made tremendous progress last year with the
tilsotolimod clinical development program, and we are positioned
well going into this pivotal year,” stated Vincent Milano, Idera’s
Chief Executive Officer. “Our ILLUMINATE-301 registrational
trial of tilsotolimod in anti-PD-1 refractory metastatic melanoma
is enrolling at a rate that dramatically exceeded our
expectations. We expect to complete enrollment this quarter,
setting up the possibility of data before the end of this
year. We believe the rapid enrollment in this randomized
trial is a testament to the critical unmet need for this patient
group as well as to the growing appreciation from global
investigators for both intratumoral administration and the
mechanism of action of tilsotolimod.”
Continued Milano, “We also will add to the overall
body of clinical evidence for tilsotolimod with additional data
readouts expected in the second quarter. Final analysis of
ILLUMINATE-204 will include median overall survival (OS) for the
first time, and ILLUMINATE-206 will provide safety and preliminary
efficacy in microsatellite-stable colorectal cancer (MSS-CRC) as a
triple combination of ipilimumab, nivolumab and tilsotolimod in
this immunorefractory indication.”
“Lastly, we recently entered into a financing
agreement that provides financial resources for these critical
catalysts and beyond. Overall, we are looking forward to 2020
and delivering on the goals we set for patients and our investors
when we initiated the development of tilsotolimod.”
ILLUMINATE (tilsotolimod) Clinical
Development Program
ILLUMINATE 301 – Randomized phase
3 trial of tilsotolimod in combination with ipilimumab versus
ipilimumab alone in patients with anti-PD-1 refractory metastatic
melanoma:
- Approximately 100 sites active in 11 countries;
- Planned enrollment target of 454 patients;
- As of January 13, 2020, 427 patients enrolled, representing 94%
enrollment; and
- Targeting completion of enrollment during Q1 2020; and data in
Q4 2020/Q1 2021.
ILLUMINATE 206 – Phase 2,
open-label, multi-cohort, multi-center study to test the safety and
effectiveness of tilsotolimod in combination with ipilimumab and
nivolumab for the treatment of solid tumors:
- Trial initiated on September 30, 2019, leading with the MSS-CRC
cohort;
- Initial safety run-in cohort of 10 patients with MSS-CRC fully
enrolled; and
- Preliminary objective response rate (ORR) and safety data from
this cohort expected in Q2 2020.
ILLUMINATE 204 – Phase 1/2 trial
of tilsotolimod in combination with ipilimumab or pembrolizumab in
patients with anti-PD-1 refractory metastatic melanoma:
- Completed enrollment with 52 patients (49 evaluable) at
tilsotolimod 8 mg with ipilimumab in February 2019; and
- Final results from the ILLUMINATE 204 trial are expected to be
released in Q2 2020;
- Data to be presented include ORR, median OS, duration of
response (DOR) and safety.
Upcoming Corporate
PresentationIdera Chief Executive Officer Vincent Milano
will provide a corporate overview at the 38th Annual J.P. Morgan
Healthcare Conference on Thursday, January 16, 2020 at 7:30 AM PT/
10:30 AM ET. The conference is being held at the Westin St.
Francis Hotel in San Francisco, CA. A copy of the Company’s
J.P. Morgan corporate presentation will be posted on the Investors’
page of the Company’s corporate website on Wednesday January 15,
2020 prior to the opening of the U.S. markets.
Live audio webcast of Idera’s presentations will be
accessible in the Investors section of Idera’s website at
http://www.iderapharma.com. Archived versions will also be
available on the Company’s website after the event for 90
days.
About Tilsotolimod
(IMO-2125)Tilsotolimod is an investigational TLR 9 agonist
that received Fast Track Designation from the U.S. Food and Drug
Administration (FDA) in 2017 for the treatment of anti-PD-1
refractory melanoma, in combination with ipilimumab as well as
orphan drug designation from the FDA for the treatment of melanoma
Stages IIb to IV. It signals the immune system to create and
activate cancer-fighting cells (T-cells) to target solid
tumors. Currently approved immuno-oncology treatments,
specifically check-point inhibitors, provide benefit for some
patients, but these therapies are limited in patients whose immune
responses are missing or weak. Intratumoral injections with
tilsotolimod are designed to selectively enable the tumor-specific
T-cells to recognize and attack cancers that remain elusive and
unrecognized by the immune system exposed to checkpoint inhibitors
alone, while limiting toxicity or impact on healthy cells in the
body.
About Idera Pharmaceuticals
Harnessing the approach of the earliest researchers in
immunotherapy and the Company’s vast experience in developing
proprietary immunomodulatory platforms, Idera’s TLR agonist
development program is focused on priming the immune system to play
a more powerful role in fighting cancer, ultimately increasing the
number of people who can benefit from immunotherapy. Idera also
continues to focus on the acquisition, development and ultimate
commercialization of drug candidates for both oncology and rare
disease indications characterized by small, well-defined patient
populations with serious unmet needs. To learn more about Idera,
visit www.iderapharma.com.
Idera Forward Looking Statements
This press release contains forward-looking statements within the
meaning of the safe harbor of the Private Securities Litigation
Reform Act of 1995 and the Federal securities laws. All statements,
other than statements of historical fact, included or incorporated
in this press release, including statements regarding the Company's
strategy, financial position and clinical trial plans, including
enrollment and timing of results, are forward-looking statements.
The words "believes," "anticipates," "estimates," "plans,"
"expects," "intends," "may," "could," "should," "potential,"
"likely," "projects," "continue," "will," “schedule,” and "would"
and similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. These forward-looking statements are
predictions based on the Company’s current expectations and
projections about future events and various assumptions. Idera
cannot guarantee that it will actually achieve the plans,
intentions or expectations disclosed in its forward-looking
statements and you should not place undue reliance on the Company's
forward-looking statements. These forward-looking statements
involve known and unknown risks, uncertainties, and other factors,
which may be beyond Idera’s control, and which may cause the actual
results, performance, or achievements of the Company to be
materially different from future results, performance, or
achievements expressed or implied by such forward-looking
statements. There are a number of important factors that could
cause Idera's actual results to differ materially from those
indicated or implied by its forward-looking statements including,
without limitation: whether the Company’s cash resources will be
sufficient to fund the Company’s continuing operations and the
further development of the Company’s programs; whether interim
results from a clinical trial will be predictive of the final
results of the trial; whether results obtained in preclinical
studies and clinical trials will be indicative of the results that
will be generated in future clinical trials, including in clinical
trials in different disease indications; whether products based on
Idera's technology will advance into or through the clinical trial
process when anticipated or at all or warrant submission for
regulatory approval; whether such products will receive approval
from the FDA or equivalent foreign regulatory agencies; whether, if
the Company's products receive approval, they will be successfully
distributed and marketed; and whether the Company's collaborations
will be successful. All forward-looking statements included in this
release are made as of the date hereof, and are expressly qualified
in their entirety by this cautionary notice, including, without
limitation, those risks and uncertainties described in the
Company’s Annual Report on Form 10-K for the year ended December
31, 2018, and otherwise in the Company’s filings and reports filed
with Securities and Exchange Commission. While Idera may elect to
do so at some point in the future, the Company does not assume any
obligation to update any forward-looking statements and it
disclaims any intention or obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise, except as may be required by law.
IDERA PHARMACEUTICALS Contacts:
Robert A. Doody, Jr.SVP, Investor Relations &
CommunicationsPhone (484) 348-1677rdoody@iderapharma.com
John J. KirbySVP, Chief Financial OfficerPhone
(484) 348-1627jkirby@iderapharma.com
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